Pilot Study of the 'Thriving With PMDs' Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorUniversity of Regina
About this trial
This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-42
Either meeting diagnostic criteria for premenstrual dysphoric disorder (to be confirmed by researchers through daily symptom ratings for two menstrual cycles) or major depressive disorder with perimenstrual exacerbation (i.e. at least a 30% increase in 4 symptoms in the perimenstrual phase)
Disqualifiers
Taking oral contraceptives
Currently in psychotherapy
Trial design
Design model
Single group
Treatments tested in this trial
Self-directed psychotherapy program for premenstrual disorders
BehavioralThe intervention consists of receiving 11 videos that are 10-15 minutes in length along with a workbook containing homework exercises. Participants are instructed to watch the videos over the course of two menstrual cycles: the first 6 during the first cycle and the last 5 during the second cycle. Each module focuses on a different skill inspired by cognitive behavioral therapy and dialectical behavior therapy.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Self-directed psychotherapy programExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144)
Perimenstrual DRSP score during the two post-intervention menstrual cycles relative to the two pre-intervention menstrual cycles
Time frame
Baseline, 1 month post-intervention, 2 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regina
Lead sponsor
International Association for Premenstrual Disorders
Collaborator
Source ClinicalTrials.gov